[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452578":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":101,"locations":31,"responsibleParty":109,"collaborators":111,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":31,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":153,"whyStopped":31,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":31},{"fullName":5,"class":6},"International Agency for Research on Cancer","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"3-doses HPV vaccination","EXPERIMENTAL","Participants will receive three doses of HPV vaccine at 0, 2, and 6 months",[13,14],"Biological: HPV vaccine","Diagnostic Test: HPV testing",{"label":16,"type":10,"description":17,"interventionNames":18},"1-dose HPV vaccination","Participants will receive HPV vaccine at entry, and placebo (HAV vaccine) at 2 and 6 months",[13,14,19],"Biological: HAV vaccine",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo","PLACEBO_COMPARATOR","Participants will receive Hepatitis A (HAV) vaccine at 0, 2, and 6 months",[14,19],[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","HPV vaccine","Licensed HPV vaccines (bivalent, quadrivalent, or nonvalent) available in the country of the study site",[16,9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DIAGNOSTIC_TEST","HPV testing","HPV testing with partial genotyping of HPV16\u002F18 (and\u002For 45) to be used as a primary cervical screening test for all participants regardless of the study arm",[16,9,21],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"HAV vaccine","Hepatitis A virus (HAV) vaccine to be offered as a placebo",[16,21],[42,45,47,50,52,54,56,59,62,64,67,69,72,75,78,81,84,87,90,93,95,97,99],{"name":43,"affiliation":5,"role":44},"Maribel Almonte, MPH, MSc, PhD","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":5,"role":44},"Armando Baena, MSc, PhD",{"name":48,"affiliation":5,"role":49},"Rolando Herrero, MD, PhD","STUDY_CHAIR",{"name":51,"affiliation":5,"role":49},"Mathilde Forestier, PhD",{"name":53,"affiliation":5,"role":49},"Joan Valls, MSc, PhD",{"name":55,"affiliation":5,"role":49},"Laura Downham, MSc",{"name":57,"affiliation":58,"role":49},"Prajakta Adsul, MBBS, MPH, PhD","University of New Mexico",{"name":60,"affiliation":61,"role":49},"Hennie Botha, MD, PhD","University of Stellenbosch",{"name":63,"affiliation":61,"role":49},"Haynes van der Merwe, MD, PhD",{"name":65,"affiliation":66,"role":49},"Motshedisi Sebitloane, MBChB, PhD","University of KwaZulu",{"name":68,"affiliation":66,"role":49},"Themba Ginindza, MSc, MPH, PhD",{"name":70,"affiliation":71,"role":49},"Samah R Sakr, MBChB","Coptic Hope Center",{"name":73,"affiliation":74,"role":49},"Michael H Chung, MD, MPH, PhD","Emory University",{"name":76,"affiliation":77,"role":49},"Xolisile Dlamini, MPH","National Cancer Control Unit - Eswatini Ministry of Health",{"name":79,"affiliation":80,"role":49},"Florence A Anabwani-Richter, MBChB, MPH","Baylor College of Medicine Children's Foundation",{"name":82,"affiliation":83,"role":49},"Lisbeth Lebelo, PhD","Sefako Makgatho Health Sciences University",{"name":85,"affiliation":86,"role":49},"Marleen Temmerman, MD, PhD","Aga Khan University",{"name":88,"affiliation":89,"role":49},"Jean-Marie Dangou, PhD","World Health Organization (AFRO\u002FWHO)",{"name":91,"affiliation":92,"role":49},"Nathalie Broutet, MD, PhD","World Health Organization",{"name":94,"affiliation":92,"role":49},"Sami L Gottlieb, PhD",{"name":96,"affiliation":92,"role":49},"Paul Bloem, MSc",{"name":98,"affiliation":92,"role":49},"Soe Soe Thwin, MSc, PhD",{"name":100,"affiliation":92,"role":49},"Ajay Rangaraj, MD, MSc",[102,106],{"name":46,"role":103,"phone":104,"phoneExt":31,"email":105},"CONTACT","+33 4 72 73 88 55","baenaa@iarc.who.int",{"name":43,"role":103,"phone":107,"phoneExt":31,"email":108},"+33 4 72 73 84 92","almontem@iarc.who.int",{"type":110,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[112,113,114,115,117,118,121,122,123,124],{"name":58,"class":6},{"name":61,"class":6},{"name":66,"class":6},{"name":71,"class":116},"UNKNOWN",{"name":74,"class":6},{"name":119,"class":120},"Ministry of Health, Swaziland","OTHER_GOV",{"name":80,"class":6},{"name":83,"class":6},{"name":86,"class":6},{"name":92,"class":6},"100452578","phase-3-integration-of-hpv-vaccination-and-hpv-based-cervical-screening-into-arv-clinics-the-h2victory-trial-100452578",false,"NCT05173324","Integration of HPV Vaccination and HPV-based Cervical Screening Into ARV Clinics: the H2VICTORY Trial","Integration of HPV Vaccination and HPV-based Cervical Screening in Young Adult WLWH Into ARV Clinics to Speed the Pathway Towards Cervical Cancer Elimination: the H2VICTORY Trial","H2VICTORY","Inclusion Criteria:\n\n* Women living with HIV (WLWH)\n* Aged 25-35 years\n* Attending ARV clinics\n* Mentally competent to give informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Less than 3 months postpartum\n* Women without a cervix (e.g., hysterectomy)\n* Plans to move to another city in the next 2 years or any other reason to prevent finalizing the study","FEMALE","25 Years","35 Years",{"count":137,"type":138},8000,"ESTIMATED","INTERVENTIONAL",[141],"PHASE3","A 3-dose HPV vaccination scheme has shown to be safe and immunogenic in people living with HIV (PLWH), although evidence on 1-dose, which is important to improve coverage, is scarce. Available HPV vaccines only prevent new infections. Since a large fraction of WLWH is already infected with HPV (\\>50%), vaccines' efficacy to prevent HPV infections (and therefore cervical disease) in this population is limited. Current WHO cervical cancer screening guidelines recommend treatment of the transformation zone (TZ) of WLWH who harbor HPV infections either at initial screening or one year later. Therefore, HPV vaccination at the time of the screening may improve vaccines efficacy conferring protection to newly growing cells of the treated TZ against HPV infections\u002Fre-infections. Consequently, a dual-intervention of HPV vaccination and HPV-based cervical screening in WLWH may alleviate the burden of HPV-related disease by improving HPV vaccination efficacy while extending cervical screening intervals. Nevertheless, implementing the dual-intervention may be challenging particularly in some contexts without well-established cervical cancer screening such as sub-Saharan African (SSA) countries. However, in these countries, at least 60% of PLWH regularly attend ARV clinics to be monitored and receive ARV treatment (cART). Therefore, integrating the dual-intervention into ARV clinics seems to be an efficient approach to reduce loss to follow-up while improving overall coverages of HPV vaccination and cervical screening. Such integration may also facilitate the implementation of a platform for the delivery of other HPV-related preventive measures such as HPV therapeutic vaccines.\n\nNevertheless, little is known about the efficacy of HPV vaccination in WLWH to prevent HPV infections and HPV-related diseases, especially in young adults. Moreover, evidence on how best to conduct cervical cancer prevention, particularly recently released WHO guidelines, through ARV clinics is limited. Therefore, IARC\u002FWHO in collaboration with HRP\u002FWHO and colleagues in SSA proposes to conduct a hybrid effectiveness-implementation trial (H2VICTORY) to evaluate the effectiveness of the dual-intervention of HPV vaccination and HPV-based cervical screening to reduce HPV infections (and therefore, the risk of cervical cancer) in WLWH aged 25-35 years while conducting implementation research to identify facilitators and barriers for adoption and sustainability of proven evidence-based cervical cancer prevention approaches integrated into ARV clinics across sub-Saharan Africa.",[144],"HPV Infection",[146,147,148,149,150,151,152],"HPV vaccination","HPV-based cervical screening","HIV infection","Cervical ablative treatment","Antiretroviral clinics","Implementation research","Hybrid effectiveness-implementation trials","NOT_YET_RECRUITING","2022-08-02",{"date":156,"type":157},"2022-08-03","ACTUAL",{"date":159,"type":138},"2023-02-01",{"date":161,"type":138},"2027-06-30",{"name":5,"class":6}]